FDA Approves Bristol Myers Squibb's Combination Therapy For Colorectal Cancer Patients With Certain Type Of Gene Mutation

Friday, the FDA granted accelerated approval to Bristol Myers Squibb & Co’s BMY Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results.

Bristol Myers Squibb added adagrasib via its $5 billion Mirati Therapeutics Inc. deal.

The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study, which evaluated Krazati (600 mg tablets administered orally twice daily) in combination with cetuximab in 94 patients with heavily pretreated CRC harboring a KRASG12C mutation.

The study met its primary endpoint, with a confirmed ORR of 34% for Krazati with cetuximab, all of which were partial responses.

The median DOR, one of the secondary endpoints, was 5.8 months.

Current late-line standard of care options results in limited response rates (ORR 1-6%) after progression on chemotherapy ± VEGF/VEGFR inhibitors.

The company partnered with QIAGEN NV QGEN to develop a tissue-based companion diagnostic (CDx) for Krazati that is now available.

The company added that Krazati is associated with the following Warnings & Precautions: Gastrointestinal adverse reactions including diarrhea, nausea, and vomiting, QTc interval prolongation, hepatotoxicity, and interstitial lung disease (ILD)/pneumonitis.

In 2022, Krazati was granted accelerated approval for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, who have received at least one prior systemic therapy.

Reuters, citing a Morning Star analyst, notes that “The approval helps justify Bristol’s decision to buy Mirati.” The analyst estimates just over a billion dollars in annual sales for Krazati.

Price Action: BMY shares are up 0.38% at $42.09 during the premarket session at last check Monday.

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